AbbVie bags EC approval for Maviret to treat acute HCV infection

AbbVie announced that the European Commission approved Maviret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. With this approval, Maviret is now the only treatment approved in the European Union for both acute and chronic HCV infection.

"More than 12 million people in Europe live with hepatitis C, underscoring the need for earlier treatment," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "Today's European Commission approval of Maviret for acute hepatitis C infection enables earlier intervention, aiming to help more people access curative therapy at the time of diagnosis, while accelerating progress toward the goal of eliminating hepatitis C as a public health threat."

HCV is a highly infectious blood-borne disease that often goes undetected because people may not show symptoms. While HCV is curable, many people remain undiagnosed. If left untreated, HCV can progress to severe liver complications, including cirrhosis and end-stage liver disease. Current clinical guidance supports treating nearly all people with acute or chronic HCV infection.

"People living with HCV infection frequently face delayed treatment, leading to loss to care and onward transmission," said Massimo Puoti, MD, director of the Infectious Diseases Department at Niguarda Hospital in Milan, Italy. "With this approval, healthcare professionals across the European Union now have an approved treatment option to treat patients at the earliest stage of infection, supporting prompt intervention and helping to reduce transmission, disease progression, and long-term complications for people living with hepatitis C."

Globally, HCV poses a substantial health and economic burden, with over 200,000 deaths each year from liver cancer. People living with HCV are up to 17 times more likely to develop liver cancer than those unaffected.

The approval was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of Maviret eight-week treatment regimen in patients with acute HCV infection.

The study results showed Maviret to be a highly efficacious treatment for people with acute HCV. The majority of the adverse events reported were mild or moderate in severity. The most common adverse events were fatigue, diarrhea, headache, and asthenia.AbbVie continues to collaborate with global regulatory authorities to support access to Maviret for people living with acute HCV infection. Maviret is approved in the United States, Saudi Arabia, New Zealand, Canada, Taiwan, Australia and Argentina for the treatment of acute and chronic HCV infection in adults and children aged 3 years and older.

The overall safety profile observed in the M20-350 study was similar to that observed in patients with chronic HCV infection. No serious adverse reactions or adverse reactions leading to treatment discontinuation that were judged as treatment-related were observed among patients with acute HCV infection. The most commonly reported adverse reactions were fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%).

https://en.wikipedia.org/wiki/Glecaprevir/pibrentasvir

MORE : AbbVie bags EC approval for Maviret to treat acute HCV infection

Sanofi announces approvals for Wayrilz and Cenrifki

The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing and manufacturing authorization to French pharma major Sanofi’s (Euronext: SAN) Wayrilz (rilzabrutinib), a novel oral reversible Bruton’s tyrosine kinase inhibitor (BTKi).

The drug is authorized for the treatment of persistent or chronic immune thrombocytopenia (ITP) in patients who do not respond sufficiently to other treatments or in whom tolerability is considered to be problematic. Wayrilz can help address the underlying causes of the disease, through multi-immune modulation, targeting key pathways across the immune system.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Tolebrutinib

https://en.wikipedia.org/wiki/Tolebrutinib

Wayrilz (rilzabrutinib)

https://en.wikipedia.org/wiki/Rilzabrutinib

Sanofi announces approvals for Wayrilz and Cenrifki

Tea Plants' Secret Weapon Against Disease: The Power of Sakuranetin

Tea plants use sakuranetin as a natural antifungal shield against anthracnose, offering hope for greener farming Tea, one of the world's most cherished beverages, may have a powerful natural defense system hidden within its leaves

Scientists from the Zhejiang Academy of Agricultural Sciences have uncovered a molecular mechanism that enables certain tea plants to resist anthracnose—a destructive fungal disease that causes significant losses in tea plantations worldwide.

Their research reveals that a naturally occurring compound called sakuranetin (SAK) acts as a potent antifungal shield, helping resistant tea varieties stop infections before they spread.

The findings, published in Horticulture Research, provide fresh insights into how tea plants defend themselves and could open new avenues for sustainable tea cultivation. 

Understanding Tea Plant Resistance

Anthracnose, caused by the fungus Colletotrichum camelliae, is among the most damaging diseases affecting tea crops. The pathogen spreads through wind and rain, infecting leaves and reducing both yield and quality.

Current control methods rely heavily on synthetic fungicides, raising concerns about environmental impact and chemical residues in a beverage consumed globally as a direct infusion.

Although tea plants naturally produce defensive compounds such as catechins and caffeine, researchers wanted to understand how the plant activates additional defenses after a fungal attack.

To investigate, the team compared two tea cultivars with contrasting disease responses: 'Zijuan', which is naturally resistant to anthracnose, and 'Longjing43', a widely cultivated but more susceptible variety.

The Science Behind Sakuranetin

The researchers discovered that when C. camelliae attacks, the resistant cultivar 'Zijuan' rapidly produces high levels of sakuranetin, a plant defense molecule known as a phytoalexin. This compound creates a hostile environment for the fungus, significantly restricting its growth.

Laboratory tests revealed that sakuranetin displayed stronger antifungal activity against C. camelliae than epigallocatechin gallate (EGCG), one of tea's most abundant and well-known catechins.

The key to this defense lies in an enzyme called naringenin 7-O-methyltransferase (NOMT), produced by the CsNOMT gene. The enzyme converts a flavonoid precursor, naringenin, into sakuranetin, effectively equipping the plant with a powerful chemical weapon.

Researchers observed that infected 'Zijuan' leaves accumulated substantial amounts of sakuranetin, whereas the susceptible cultivar 'Longjing43' produced very little.

A Molecular Relay Activates the Defense

The study uncovered an intricate defense pathway controlled by the plant hormone jasmonic acid (JA), a key regulator of immune responses in plants.

When the fungus invades, JA signaling becomes activated. This, in turn, stimulates a transcription factor called CsMYC2.1, which binds directly to the promoter region of the CsNOMT gene and switches it on.

Once activated, CsNOMT boosts sakuranetin production, creating a rapid chemical barrier against fungal invasion.

Researchers describe this process as a molecular relay:

Pathogen attack → JA signaling → CsMYC2.1 activation → CsNOMT expression → Sakuranetin production → Antifungal defense

This cascade was considerably stronger in 'Zijuan' than in 'Longjing43', explaining why the resistant cultivar is better protected from anthracnose.

Experiments Confirm the Protective Role

To confirm the importance of this pathway, scientists altered the expression of the CsNOMT gene.

When CsNOMT was silenced, sakuranetin levels dropped and plants became more vulnerable to anthracnose infection. Conversely, increasing CsNOMT expression elevated sakuranetin production and significantly reduced disease symptoms.

These experiments demonstrated that disease resistance is not determined by the presence of a single gene alone, but by how efficiently the plant activates its entire defense network when challenged by a pathogen.

Implications for Sustainable Tea Farming

The discovery has important implications for the future of tea cultivation.

The genes CsNOMT and CsMYC2.1 could serve as molecular markers, allowing breeders to identify and develop anthracnose-resistant tea varieties more quickly through marker-assisted breeding.

In addition, sakuranetin itself may provide a blueprint for developing natural biopesticides or plant defense stimulants that reduce reliance on synthetic fungicides.

Such approaches could help tea growers improve crop resilience while addressing growing concerns over environmental sustainability and chemical residues.

Beyond Tea: A Broader View of Plant Immunity

The findings also broaden scientists' understanding of plant immunity. While phytoalexin-based defenses have been extensively studied in crops such as rice and model plants, this research demonstrates that woody perennial crops like tea also rely on inducible chemical defenses to combat disease.

By linking hormone signaling, gene regulation, metabolite production, and disease resistance into a single framework, the study offers one of the clearest pictures yet of how tea plants mount a sophisticated defense against fungal attack.

For tea lovers around the world, this hidden molecular shield may one day help ensure healthier crops, more sustainable farming practices, and a more resilient future for one of the world's most beloved beverages.

Ref : JA–CsMYC2.1–CsNOMT–sakuranetin module contributes to differential anthracnose resistance in Camellia sinensis - (https://academic.oup.com/hr/article/13/5/uhag022/8444634?login=false)

https://en.wikipedia.org/wiki/Sakuranetin

More: 

Tea Plants' Secret Weapon Against Disease: The Power of Sakuranetin

FDA Approves Baxfendy (baxdrostat) as the First Aldosterone Synthase Inhibitor Treatment for Adults with Hypertension

AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

• Approval based on BaxHTN Phase III results showing statistically significant and clinically meaningful reduction in systolic blood pressure in patients with uncontrolled or resistant hypertension
• Baxfendy 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo- adjusted) from baseline in BaxHTN trial

There are 1.4 billion people worldwide living with hypertension.¹ In the US, approximately 50% of patients living with hypertension who are already taking multiple antihypertensive medications still struggle with persistently elevated blood pressure,² which is a leading risk factor for cardiovascular disease and premature death.^3,4 Hypertension is the most prevalent and significant modifiable cardiovascular risk factor worldwide, accounting for more deaths and disability than any other modifiable risk.^5-7

Baxfendy is a first-in-class, highly selective and potent ASI designed to lower blood pressure in a new way by specifically inhibiting the production of aldosterone,⁸ a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney problems.^9-11

The approval by the US Food and Drug Administration (FDA) was based on positive results from the BaxHTN Phase III trial,¹² with Baxfendy demonstrating statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2mg and 1mg doses in patients with uncontrolled and resistant hypertension on two or more medications. Baxfendy was generally well-tolerated with no unanticipated safety findings.

Dr. Bryan Williams, Chair of Medicine at University College London, and BaxHTN primary investigator, said: “We have been waiting for an innovative medication like Baxfendy for hypertension for many years. Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension. In addition, the nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients. Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.”

John M. Clymer, Executive Director, National Forum for Heart Disease & Stroke Prevention, said: “Hypertension remains a staggeringly widespread silent killer and a leading risk factor for stroke, heart attack, kidney damage and dementia. Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments. Innovative, new treatments could help millions protect their heart, kidney and brain health.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The approval of Baxfendy offers a much‑needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines. In the US, about 23 million patients are uncontrolled despite being on two or more medicines for hypertension, which is a disease that has seen little therapeutic progress for the past two decades.”

In the BaxHTN Phase III trial,¹³ published in the New England Journal of Medicine,¹² Baxfendy (baxdrostat) demonstrated statistically significant and clinically meaningful efficacy for the treatment of patients with hypertension on top of standard of care. At week 12, the absolute reduction from baseline in mean seated SBP was 15.7 mmHg (95% confidence interval [CI], -17.6 to -13.7) and placebo-adjusted reduction was 9.8 mmHg (95% CI, -12.6 to -7.0; p<0.001) for the 2mg dose. For the 1mg dose, the absolute reduction from baseline was 14.5 mmHg (95% CI, -16.5 to -12.5) and placebo-adjusted reduction was 8.7 mmHg (95% CI, -11.5 to -5.8; p<0.001). The reduction in mean seated SBP with placebo was 5.8 mmHg (95% CI, -7.9 to -3.8). Results were consistent across both uncontrolled and treatment-resistant subgroups.

https://en.wikipedia.org/wiki/Baxdrostat

More: 

FDA Approves Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for Nonprescription Use in the Treatment of Acne

In continuation of my update on Adapalene

Galderma (SIX: GALD), the pure-play dermatology category leader,  announced   the United States (U.S.) Food and Drug Administration (FDA)  approval of  Differin Epiduo Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care.

Adapalene

• unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older
• Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin and Epiduo heritage
• Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter
• The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone

This milestone represents yet another example of Galderma’s unique Integrated Dermatology strategy, demonstrating how proven innovations from its Therapeutic Dermatology portfolio can further strengthen its Dermatological Skincare offerings. The Prescription‑to‑OTC transition highlights Galderma’s scale and expertise in successfully commercializing dermatology innovations across the full spectrum of acne care.

With the approval of Differin Epiduo OTC, Galderma is bringing its proven acne science to a broader population of acne sufferers through wider access to a dermatologist-recommended, prescription-strength treatment, while further strengthening its global leadership in acne care.

Delivering continued innovation in acne prevention and care

Differin Epiduo is a topical acne treatment that combines adapalene, a third-generation retinoid originally discovered and developed by Galderma to address the stability and tolerability challenges of earlier retinoids, with benzoyl peroxide (0.1/2.5%). This adapalene molecule reflects Galderma’s long-standing leadership in retinoid science, delivering an innovation-led approach that goes beyond traditional OTC acne actives. Together, these two dermatologist-trusted ingredients address key biological drivers of acne – clearing clogged pores, killing acne-causing bacteria, and reducing acne inflammation – to help clear acne, prevent future breakouts and improve skin tone, texture, and overall appearance.^1,2

The formulation is further powered by its Simulgel™ Gel Base, which stabilizes and evenly distributes both active ingredients while maintaining benzoyl peroxide’s efficacy and improving overall tolerability. This enables a simple, one-pump, once-daily regimen – a level of ease that is critical to building consistent routines and achieving clearer skin over time.

“This approval marks an important milestone in acne care and reflects Galderma’s longstanding leadership in acne and retinoid science. Differin Epiduo pairs two complementary, evidence‑based actives: adapalene, a highly stable and well‑tolerated retinoid developed by Galderma, and benzoyl peroxide, a proven antimicrobial agent. This retinoid-benzoyl peroxide combination aligns with dermatology guidelines, which strongly recommend using both together as a first‑line, multimodal approach to acne treatment. Bringing this scientifically grounded combination to the OTC setting allows us to extend that legacy to patients across the U.S. while preserving the clinical rigor that underpins its effectiveness.” BILL ANDRIOPOULOS, PH.D., HEAD OF GLOBAL MEDICAL AFFAIRS, GALDERMA

Clinical data supporting the approval demonstrated:

• Proven efficacy across multiple randomized, controlled Phase 3 studies, with adapalene/benzoyl peroxide gel consistently outperforming adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory, non-inflammatory, and total acne lesions, as well as Investigator Global Assessment (IGA) success rates (“clear” or “almost clear”).^3-5
• Clinically meaningful improvement in lesion counts seen as early as Week 1, with antimicrobial activity beginning on Day 1 and up to 70.3% reduction in inflammatory acne lesions at Week 12.³
• Sustained efficacy with long‑term use, maintaining ~65% total lesion reduction in a single arm study through 12 months, which supports once‑daily, ongoing acne control.⁶
• Proven efficacy across diverse patient populations, with consistent results and favorable tolerability across skin tones.

“This milestone reflects a meaningful advancement for patients, as it expands access to a clinically proven, dual-active acne solution without the need for a prescription. In my practice, the combination of easy access and a simple, once-daily application can help patients use treatment more consistently in their treatment journey for the best possible outcomes.” HEATHER WOOLERY-LLOYD, MD, BOARD-CERTIFIED DERMATOLOGIST, UNITED STATES

First approved as a prescription treatment, Epiduo^® (Adapalene 0.1% and Benzoyl Peroxide 2.5%) Gel has been trusted by dermatologists for more than 15 years, with millions of prescriptions written worldwide. Its global clinical legacy includes more than ten Galderma studies involving over 3,200 patients, along with extensive third-party studies, across a wide range of ages, skin tones and acne severity. With this Prescription-to-OTC switch, Galderma continues to play a defining role in shaping modern acne care, leveraging its own proprietary science to advance dermatology, and expanding access to effective treatments.

Differin Epiduo will be available over-the-counter at most major retailers, including Walmart, Ulta, Target and Amazon, beginning in the summer of 2026. With a commitment to providing effective solutions across consumers’ acne journey, the Differin portfolio also includes cleansers, treatments, and moisturizers to support and provide wholistic solutions. For more information on Differin Epiduo and other Differin products, please visit www.differin.com and join the Differin community on Instagram, Facebook and YouTube to stay up to date on the latest innovations.

https://en.wikipedia.org/wiki/Adapalene

FDA Grants Accelerated Approval to Hepcludex for HDV

Gilead Sciences, Inc. (Nasdaq: GILD)  announced  the U.S. Food and Drug Administration (FDA)  granting  accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States.

• Chronic HDV is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure and liver-related death
• Approval introduces the first FDA-approved therapy for this disease with limited treatment options and high unmet need

The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotransferase (ALT), supported primarily by data from the pivotal, controlled Phase 3 MYR301 study. At Week 48, the study demonstrated a statistically significant improvement versus the control (delayed treatment) group in a combined virologic and biochemical response. Improvement in disease-related clinical outcomes has not been established. Continued approval for the approved indication may be contingent on verification and description of clinical benefit in a confirmatory trial.

Chronic HDV is considered the most severe form of viral hepatitis and is associated with a markedly higher risk of rapid disease progression, liver failure, and mortality compared with HBV alone. In the United States, studies in general populations have estimated that HDV affects between 2% and 4% of individuals who have chronic hepatitis B virus (HBV), representing ~40,000-80,000 people.

“Hepatitis delta virus is associated with rapid progression of liver disease and a high risk of serious or even life-threatening liver-related complications,” said Dr. Ira Jacobson, MD, Department of Medicine at NYU Grossman School of Medicine. “For patients, an HDV diagnosis means managing two distinct viral liver diseases—hepatitis B and hepatitis D—each contributing to disease progression, monitoring demands, and treatment complexities. The approval of Hepcludex for chronic HDV represents a critical advancement, introducing a long-awaited option that begins to address a significant unmet medical need and has the potential to meaningfully alter the course of this devastating disease for people living with HDV in the United States.”

MYR301 (NCT03852719) evaluated the efficacy and safety of Hepcludex in adults with chronic HDV, with treatment administered for up to 144 weeks followed by 96 weeks of off-treatment follow-up. Hepcludex met its primary endpoint at Week 48, with continued treatment, demonstrated sustained efficacy and was generally well tolerated through up to 144 weeks of on-treatment exposure.

“The approval of Hepcludex represents a historic milestone for people living with HDV in the United States, marking the first FDA-approved treatment for HDV,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “This reflects years of close engagement with the FDA and the application of rigorous science to address a serious disease with long-standing unmet need. With Hepcludex, we now have the opportunity to deliver a meaningful clinical advancement that has the potential to change the trajectory of HDV for patients in the U.S.”

U.S. Access and Hepcludex Approval Across Markets

The Gilead Support Path^® Program offers information and resources to help patients diagnosed with chronic HBV, HDV and hepatitis C virus (HCV) and primary biliary cholangitis (PBC), as well as healthcare professionals, understand coverage and financial options for prescribed Gilead treatments.

Bulevirtide 2 mg is also approved for use in the European Economic Area (EEA) and other countries globally to treat people living with chronic HDV.

Please see below for U.S. Indication and Important Safety Information for Hepcludex.

U.S. Indication for Hepcludex

Hepcludex (bulevirtide-gmod) 8.5 mg for injection is indicated for the treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis.

This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

https://en.wikipedia.org/wiki/Bulevirtide

FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract Infections

In continuation of my update on cefepime

cefepime

Zidebactam

FDA approved Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. Zaynich previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.

• Zaynich is a multi- penicillin-binding protein targeting combination of the 4 th generation cephalosporin cefepime and zidebactam working synergistically against the most challenging multidrug-resistant Gram-negative bacteria
• In the Phase 3 ENHANCE-1 clinical trial, Zaynich demonstrated higher combined clinical cure and microbiologic response (composite endpoint) at the test of cure (TOC) visit versus meropenem, 89.0% vs 68.4% respectively and was generally well tolerated
• More than 2.8 million antimicrobial-resistant infections occur each year in the U.S., resulting in more than 35,000 deaths¹

“The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of Zaynich is a monumental step forward in validating a new option for these underserved populations,” said Dennis Deruelle, MD, FHM, Chief Medical Officer at Wockhardt. “This milestone underscores our commitment to addressing critical unmet needs and offers a profound sense of hope to the families we are working to serve.”

“This approval is a significant realization of our mission to provide patients with novel antibiotics that help to address one of the most urgent global health threats—antimicrobial resistance,”² said Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group. “Furthermore, Zaynich is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive an FDA approval, representing a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry.”

Zaynich, unlike most other beta-lactam combinations, targets multiple penicillin binding proteins (PBP 1a/b, 2 and 3) simultaneously. This unique, multi-target synergy provides bactericidal activity against the most challenging drug-resistant Gram-negative bacteria for which there are currently very limited treatment options.

“Multidrug-resistant bacterial infections are a substantial burden for patients and the healthcare system, as patients with these infections typically require longer, more intensive care, and are at increased risk of lifethreatening complications,” explained Keith Kaye, MD, MPH, Professor of Medicine and Division Chief for Infectious Diseases at Rutgers Robert Wood Johnson Medical School. “There is an ongoing need for new antibiotics to combat these drug-resistant pathogens, and we are pleased that this approval means patients will soon have an exciting unique option that is urgently needed in the US and worldwide.”

cUTI is responsible for over 600,000 hospitalizations in the U.S. annually. A growing number of cUTIs are caused by antimicrobial resistant bacteria, including multidrug-resistant bacteria, a leading cause of bacteremia and associated with significant morbidity and mortality and a burden on the health care system.³

The FDA approval was based, in part, on the results from ENHANCE-1, a Phase 3, randomized, double-blind, multicenter study which evaluated the efficacy, safety and tolerability of Zaynich compared with meropenem in the treatment of hospitalized adults with cUTI or acute pyelonephritis (AP). Zaynich demonstrated efficacy at the primary endpoint, achieving a composite clinical cure and microbiological response rate of 89.0% versus 68.4% for meropenem Treatment difference 20.6% (95% CI; 12.3, 29.5). Zaynich was generally well tolerated in the phase 3 study. The study enrolled 530 patients from the U.S., Europe, LATAM, China and India, and spanned across 64 sites.

Zaynich® was approved by the Drugs Controller General of India (DCGI) on May 27, 2026. Wockhardt has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency.

FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract Infections

FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

In continuation of my update on ensitrelvir

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved Xocova (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.³ This approval introduces the first and only oral option to help prevent COVID-19 after exposure in the current therapeutic landscape, addressing a critical gap in prevention. Xocova is a five-day oral regimen with three tablets taken on day one and one tablet taken on days two through five.³ The approval occurred ahead of the Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026.

• Approval is based on SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing symptomatic COVID-19 following exposure to an infected individual*
• Xocova offers a new approach to help prevent COVID-19 by blocking viral replication during the critical window between exposure and COVID-19 symptom onset^1,2

“The FDA approval of Xocova provides an important new approach to preventing COVID-19, which continues to impact lives. COVID-19 can become severe and even when mild or moderate, it can worsen or exacerbate chronic conditions or trigger new ones, including long COVID,” said Frederick Hayden, MD, Richardson Professor Emeritus of Clinical Virology and Professor Emeritus of Medicine, University of Virginia School of Medicine. “Ensitrelvir inhibits viral replication, helping protect people who have been exposed to COVID-19 from developing illness. The PEP strategy has the potential to benefit anyone who does not want to get COVID-19. It could be useful not only in household settings but also in other exposure circumstances, such as outbreaks in nursing homes, chronic or acute care facilities and following travel-related exposures.”

The approval is based on positive results from SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing symptomatic COVID-19 following exposure to an infected individual.* Xocova significantly reduced the risk of symptomatic COVID-19 by 67% in uninfected individuals following exposure to an infected individual through Day 10 compared with placebo (ensitrelvir n=1,030; placebo n=1,011). ^3,4 Overall, Xocova was generally well tolerated, with similar rates of adverse events across groups (15.1% in the Xocova group (n=1,190) and 15.5% in the placebo group (n=1,187)).⁴ The most common adverse events (regardless of causality) occurring in greater than or equal to 1% of the Xocova group and at a greater frequency compared to placebo were headache, diarrhea, and cough. ³ There were no reports of altered taste (dysgeusia) attributed to Xocova in the trial.^4,5 Results from the SCORPIO-PEP trial were published in the New England Journal of Medicine on May 14, 2026.

“The FDA approval of Xocova is an exciting new chapter in the Shionogi antiviral story, which includes innovative medicines that have changed the way we manage other viruses including HIV and influenza,” said Nathan McCutcheon, President and CEO, Shionogi Inc. “Xocova is the first and only oral option clinically proven to help prevent symptomatic COVID-19 after exposure among study participants regardless of vaccination status or baseline immunity from prior infection. With Xocova, people who are exposed to COVID-19 can act early to help protect themselves.”

The impact of this matter on the consolidated financial results for the fiscal year ending March 2027 has already been reflected in the earnings forecast announced on May 12, 2026.

The Ongoing Impact of COVID-19

COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19.⁶ The U.S. Centers for Disease and Control estimates that between October 1, 2025 and May 23, 2026 there were 3.8-12.4 million new cases in the U.S., resulting in 800,000 – 2.3 million outpatient visits, 120,000 – 240,000 hospitalizations and 13,000 - 42,000 deaths.⁷

Beyond acute infection, COVID-19 can have lasting impacts. People diagnosed with COVID-19 had increased rates of both new and worsening neurologic, cardiovascular, respiratory, and renal conditions during the year following infection.^8-17 COVID-19 also disproportionately affects older adults with greater risk for severe illness and death in close-community settings, such as long-term care facilities.¹⁸

About SCORPIO-PEP

The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of Xocova as post-exposure prophylaxis for COVID-19. The study included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. The primary analysis included 2,041 household contact participants with a central laboratory-confirmed negative SARS-CoV-2 test at baseline.

The trial was conducted from June 2023–September 2024. More than 99% of household contacts tested positive for antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins, indicating that nearly all had evidence of previous SARS-CoV-2 infection or vaccination, or both.

Study participants were randomly assigned at a 1:1 ratio to receive Xocova (375 mg on day 1 and 125 mg on days 2-5) or placebo, once daily, and began treatment within 72 hours of when the household member with COVID-19 began showing symptoms. Participants then continued Xocova (125 mg) or placebo for five days. SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual.

https://en.wikipedia.org/wiki/Ensitrelvir

FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

Psilocybin to target persistent concussion symptoms in Australia's first clinical trial

In continuation of my update on psychedelic

Monash University researchers have launched Australia's first clinical trial to test whether the psychedelic drug psilocybin is an effective treatment for persistent post-concussion symptoms.

There are few effective therapies for the debilitating long-term effects of mild traumatic brain injury, more commonly known as concussion.

But researchers now think psilocybin, a psychedelic compound found in some mushrooms, could be the answer.

A recent preclinical study from Monash University indicates that a single macrodose can reduce the symptoms that often appear after brain injury. The research is published in the journal Cell Reports Medicine.

The project will leverage leading-edge capability and a track record in neuroimaging and biomarkers of psychedelics within the Monash Trauma Group, and clinical implementation and assessment within the Clinical Psychedelic Lab.

Why researchers are hopeful

Lead researcher on the trial, Professor Terence O'Brien, head of Monash University's School of Translational Medicine, program director Alfred Brain, and deputy director of research at Bayside Health Alfred, said the clinical trial is a huge step forward and will provide hope for many patients.

"Given the lack of effective treatment options for persistent and debilitating concussion symptoms, we are excited to be studying a promising new approach," O'Brien said.

"In addition to alleviating symptoms, research suggests it can also target the biological effects concussion has on the brain."

Up to 50% of people who sustain a concussion will experience persistent post-concussion symptoms.

These commonly include cognitive and emotional issues, plus other debilitating symptoms such as headache, dizziness, irritability and sleep disturbances.

How the trial will work

The Monash-led trial will take place in Melbourne over three years, beginning in 2026.

It is Australia's first randomized, double-blind, active placebo-controlled clinical trial investigating the efficacy of psilocybin-assisted therapy for persistent post-concussion symptoms in humans.

It will study the effect of the drug on people who have had persistent post-concussion symptoms for at least six months, regardless of the cause of the original concussion.

Professor Sandy Shultz, from the Monash Trauma Group in the School of Translational Medicine, said researchers expect psilocybin will reduce neuroinflammation and enhance the brain's ability to form new neural connections.

"We will also be looking at blood and neuroimaging biomarkers in the brain so we can understand exactly what the drug is doing in the body and how it is helping reduce symptoms," Shultz said.

"These benefits could last for at least six months post-treatment, which would be a game changer, and we will test this in the trial."

Support and broader collaboration

Dr. Josh Allen, a research fellow in the Clinical Psychedelic Lab at Monash's School of Clinical Sciences, said while many think this kind of trial isn't for them, it's worth reaching out if you suffer from persistent post-concussion symptoms.

"Participants are supported every step of the way," he said.

"This includes preparation sessions before, guided care during the psychedelic experience, and integration therapy afterward.

"Our approach will promote safety and maximize benefits for all trial participants."

Dr. Paul Liknaitzky, head of the Clinical Psychedelic Lab, said the research will address a major unmet need for people with persistent post-concussion symptoms.

"We're testing a combined treatment approach that targets both the neurological and psychological drivers of patients' symptoms and functionality," Liknaitzky said.

The project is a collaboration between the university's Department of Neuroscience and Department of Psychiatry. Also part of the research team are Dr. Georgia Symons, Dr. Jennifer Makovec Knight, Dr. Zhibin Chen and Dr. Andrew Gibbons, all from Monash University, as well as Professor Karen Caeyenberghs from Deakin University, Professor Joshua Byrnes from the University of Queensland, Professor Karen Barlow from the University of Queensland, and Naomi Fuller from Connectivity Traumatic Brain Injury Australia.

Ref: https://en.wikipedia.org/wiki/Psilocybin

Psilocybin to target persistent concussion symptoms in Australia's first clinical trial

Baricitinib Exhibits Steroid-Sparing Effect in PMR Trial

In coninuation of my update on Baricitinib

Baricitinib had a significant glucocorticoid (GC)-sparing effect in people with newly diagnosed polymyalgia rheumatica (PMR), who participated in the phase 3 JAK-Spare trial, was according to results reported at the European Alliance of Associations for Rheumatology (EULAR) 2026 Annual Meeting.

GC-free remission at week 16 was achieved in nearly two thirds (65.2%) of the 23 people who had received the drug in the trial, as compared to 17.4% of the 23 people who had been treated with placebo (P < .01).

And when participants who had initially been treated with placebo crossed over to treatment with baricitinib, their GC-free remission rate at week 28 increased to 65.2%. The GC-free remission rate in the baricitinib arm also increased to 78.3%.

Study investigator Helga Lechner-Radner, MD, of the Medical University of Vienna in Vienna, Austria, reported the trial’s findings during the late-breaking abstract session. She told Medscape Medical News that the findings were “important because we do still have a lot of patients on steroids, because whenever we try to reduce or taper steroids, they relapse again.”

Baricitinib is a drug that is “efficacious and safe in many of our [rheumatic and musculoskeletal] diseases. We know the mechanism, we know the safety profile, and therefore, it also makes sense to also test this drug in this patient population,” Lechner-Radner added.

The JAK-Spare Study

The JAK-Spare study involved 46 people with recently diagnosed PMR who were recruited between July 2022 and May 2024 across five European centers. The mean age of the recruited participants was 65 years, just over half were men, and all were White.

Crucially, a very early diagnosis (within 3 weeks) was needed for inclusion so that participants had not been taking GCs for very long, Lechner-Radner said. The average disease duration before enrollment was just 16 days, and the average daily oral GC dose was 18 mg.

Participants were randomly allocated to receive baricitinib 4 mg/d or to a placebo. A rapid GC-tapering regimen was used in both arms, which aimed to reduce the dose of GCs to zero within 11 weeks rather than the usual 52 weeks. After the initial 16-week study period, patients in the placebo group crossed over to treatment with baricitinib, while those in the baricitinib arm continued treatment. Then at 28 weeks, participants in GC-free remission were randomly assigned again either to continue baricitinib 4 mg/d through week 44 or lower their dose of baricitinib to 2 mg/d, stopping it altogether from 36 to 44 weeks.

Lechner-Radner said in an interview that GCs were given from the outset in the trial in both treatment arms because the investigators felt that it would not have been ethical to give patients newly diagnosed with PMR no treatment at all.

This is in contrast to the BACHELOR trial in which baricitinib was compared against no treatment initially in the placebo arm, with intravenous (IV) and oral GCs used only as a rescue treatment from week 4 onward. However, IV GCs are not licensed for this purpose in Austria, she said, and “they have a high dropout rate because many of those patients needed to be rescued.”

Lechner-Radner also said that, as an oral tablet, baricitinib is “an easy medication [to take]” when compared to those that require injection.

Reductions in GC Use

Assessment at week 28 showed continued improvement in the baricitinib arm, with 78.3% of participants in GC-free remission, but 65.2% of those originally in the placebo group were also now in GC-free remission, up from 17.4% at 16 weeks.

The time to relapse was significantly longer with baricitinib than placebo (P = .008). Participants in the baricitinib arm also took a lower median cumulative GC dose than those in the placebo group, at 736 mg vs 1065 mg at 16 weeks (P = .015) and 736 mg vs 1086 mg at 28 weeks (P = .013).

After re-randomization of the 33 patients who were in GC-free remission at 28 weeks, GC-free remission continued out to 44 weeks in 93.3% of those still taking baricitinib 4 mg/d and in 72.2% of those who tapered to 2 mg/d and then 0 mg/d (P = .186). Flare-free survival was higher among people who continued to take baricitinib 4 mg/d but was not statistically significant from those who tapered and then stopped baricitinib.

In each phase of the study, the percentages of participants with at least one adverse event were similar between the groups, at 87% in both in the first phase, 60.9% with baricitinib 4 mg/d vs 43.5% in the placebo crossover in the second phase, and 80% with baricitinib 4 mg/d vs 66.7% in those who tapered baricitinib in the third phase.

New Steroid-Sparing Option in PMR?

“With PMR, one wants to get patients off steroids as quickly as possible. Steroid therapy is quite toxic, and this is minimized by short duration of use and at a low dose,” Jonathan Kay, MD, professor of medicine and population and quantitative health sciences and the Timothy S. and Elaine L. Peterson Chair in Rheumatology at the UMass Chan Medical School in Worcester, Massachusetts, told Medscape Medical News. He was not involved in the trial.

But “if you can get someone on a medication that has less likelihood of causing toxicity than the steroid, the better that is going to be for the patient,” he added.

While these were positive data for a JAK inhibitor, Kay wondered whether such a drug would be likely to gain approval for use in this indication from regulatory authorities.

“In the United States, JAK inhibitors are restricted to patients who failed TNF [tumor necrosis factor] inhibitors,” he explained. “So will the FDA allow the label change to allow JAK inhibitors to be used in PMR before TNF inhibition?”

Kay pointed out that the interleukin 6 inhibitor sarilumab, which is given by subcutaneous injection every 2 weeks, is already approved to treat PMR.

https://en.wikipedia.org/wiki/Baricitinib

Baricitinib Exhibits Steroid-Sparing Effect in PMR Trial